MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALLIANCE II; SYRINGE, BALLOON INFLATION

Model Number	M00550601
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block d4, h4: detailed product information was not provided to bsc.We completed a good-faith effort to obtain the information.Because the product is waiting for pickup, we are unable to provide the complete unique identifier (udi) # and other product-specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii inflation syringe was used during a dilatation procedure performed on (b)(6) 2026.During the procedure, the pressure gauge on the syringe was defective.The first time it was pressurized; it did not indicate a proper pressure.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii inflation syringe was used during a dilatation procedure performed on (b)(6) 2026.During the procedure, the pressure gauge on the syringe was defective.The first time it was pressurized, it did not indicate a proper pressure.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block d4, h4: detailed product information was not provided to bsc.We completed a good-faith effort to obtain the information.Because the product is waiting for pickup, we are unable to provide the complete unique identifier (udi) # and other product-specific information.If additional details become available, a supplemental report will be submitted.Block h11: the device is currently in transit to boston scientific for evaluation and a supplemental report will be submitted following completion of the technical analysis.With all available information, boston scientific concludes the reported event of inflation device gauge reading inaccurate was not confirmed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established a review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.

• Brand Name: ALLIANCE II
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24612029
• Report Number: 3005099803-2026-00979
• Device Sequence Number: 18725731
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: (01)08714729129332
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K922573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 04/30/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/13/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown